1.
Description of the Vitalograph ALPHA TOUCH

The Vitalograph ALPHA Touch is a desktop
spirometer designed for use by trained professionals in the doctor’s
office,
clinic, hospital department, etc. for measuring and archiving tests on
human
subjects.Demographic data
are uploaded
using Spirotrac or entered via a keypad and stored, together with
spirometry
test data.Current
test data can be
viewed on the LCD, printed and downloaded to a PC.There are a variety of backup and other configuration
options.

Information about the software can be obtained
from the About box. This information can be used if any queries are
made to
Vitalograph or a service agent.

To access the About box:

Press the configuration
button on the main menu

Press about button

The main components of the ALPHA Touch device are shown in Figure 01 above.

Warning: No modification of this equipment is allowed. Any unauthorised changes to the Alpha Touch device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.

1.1 Indications for use

The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph Alpha Touch is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

1.2 Contraindications and precautions for use

No modification of this equipment is allowed. Any unauthorised changes to the Vitalograph Alpha Touch device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported.

The Vitalograph Alpha Touch is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals.

For spirometry testing a new Bacterial Vital Filter (BVF) should be used for each subject to protect both device and subject. A BVF is for single subject use only. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.

Spirometry may support or exclude diagnosis, but it cannot make one (ATS/ERS 2005).

When getting the Vitalograph Alpha Touch ready for use ensure that the ribbed side of the tubing is connected to the ribbed half of the connector as per the instructions in section 5. If tubing is connected the wrong way, spirometry results may appear to be inverted.

When using the Vitalograph Alpha Touch ensure that the flowhead connecting tube is not pinched or trapped as spirometry results may appear to be inverted.

Take care not to block the mouthpiece with the tongue or teeth during testing. A 'spitting' action or cough will give false readings.

Subject fatigue may occur during spirometry testing depending on the subjects characteristics e.g age, health status. To avoid this the subject may sit during the testing or alternatively take a break between tests. When the Alpha Touch device is used with Spirotrac a subject fatigue warning will appear after 8 manoeuvres and the maximum number of allowed manoeuvres in one session is 20.

All spirometry standards recommend checking the accuracy of lung function measuring devices at least daily with a 3-L syringe to validate that the instrument is measuring accurately. The Vitalograph Alpha Touch should never be outside accuracy limits. In normal use, calibration traceability certification is recommended as a part of the routine annual service. Accuracy should also be checked after cleaning or disassembling the spirometer for any reason, after adjusting calibration or if the flowhead or device has been dropped.

Operating the Vitalograph Alpha Touch device from the USB is not possible. The USB can be used to re-charge the batteries only.

Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph.

Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. NON MEDICAL EQUIPMENT MUST BE KEPT OUTSIDE THE PATIENT ENVIRONMENT.
Portable and mobile RF communications equipment can affect medical electrical equipment.

2. Main Components of the Vitalograph ALPHA TOUCH

A

P.C Software

B

Medically
Approved Power Supply

C

Flowhead

D

Flowhead
Connection Tubing

E

Colour LCD and
Touch Panel Display

F

Power LED and
Keypad (Up/Down/Enter/Clear)

G

USB
Cable

H

Internal
Thermal Printer

3. Features
of the Vitalograph ALPHA TOUCH

The Vitalograph ALPHA Touch features include:

Touch screen color display or buttons

Clear sounds for audio feedback

Choice of child incentive displays

Fully customisable report format

Automatic download of new subjects from Spirotrac

10,000 subject test memory

Automatic upload of all test data to Spirotrac

Pre/post bronchodilator comparison

Choice of predicted values and languages

Diagnostic interpretation options

Lung age for adults and adolescents

Real-time test quality prompts

Vitalograph PC software included

Stylus

Can enter subject details on device

Very high accuracy, linearity and stability

Integral printer for instant results or printing to the
Vitalograph Report Utility

Simple cleaning. The flowhead completely dismantles for
washing, disinfecting or even autoclaving

4. Getting the Vitalograph ALPHA TOUCH Ready
For Use

Note: First check that the contents of the packaging correlate with what is outlined on the contents label on the inside of the packaging carton. If the device has just been unpacked or transported, ensure that it is left sitting, fully powered, in its test environment for at least an hour before use.

Attach the flowhead to the
Vitalograph ALPHA Touch by the dual silicone tubing (Flowhead
Connection Tube). Ensure that the coloured/ribbed tapping on the
flowhead is connected to the ribbed side of the connection in the
housing.

Open
the printer door and feed the paper through
the printer (See section Fitting a New Paper Roll).

Only
use the Vitalograph ALPHA Touch with the
purpose-built low voltage power supply unit with which it is supplied.
Attempted use with other power sources may cause irreparable damage and
invalidate the warranty. The output from the power supply is 12 volts
DC.

Connect
the jackplug from the power supply into the
socket on the rear of the Vitalograph ALPHA Touch. Plug the mains plug
into a
suitable socket, operate the On/Off switch on the rear of the
instrument and
the Vitalograph ALPHA Touch is ready for use.

For
portability the Vitalograph ALPHA Touch comes
fitted with rechargeable batteries, which allows the device to be used
for a
period of time without the mains connected.

5. Power Management in the Vitalograph ALPHA Touch

The Vitalograph ALPHA Touch can be powered using the 12V low
voltage
Power Supply unit with which it is supplied or from the internal
Battery Pack. When powered from the low voltage Power Supply the LED on
the front face on the device will be green. The LED will be orange when
the device is powered from the Battery Pack.

The Power Supply unit should be checked regularly and replaced when necessary.

5.1 Battery
Pack

The
Vitalograph ALPHA Touch is fitted with a rechargeable Battery Pack.
This allows the device to be used without the 12V Power Supply
connected. The battery pack can be re-charged by plugging in the 12 V
Power Supply. To fully re-charge switch off the Vitalograph ALPHA Touch
and leave it plugged in over-night.

The battery pack can
also be re-charged by connecting the device to a PC via the USB cable.
The USB connector is located on the right side of the device.
Switch off the Vitalograph ALPHA Touch when re-charging the batteries
via USB.

The recommended battery pack replacement interval is 3 years. Battery replacement should be carried out only by the manufacturer, the approved importer or by Service Agents specifically approved by Vitalograph.

Note: Operating
the Vitalograph ALPHA Touch device from the USB is not possible. The
USB can be used to re-charge the batteries only.

5.2
Battery Low Detect

The
Vitalograph ALPHA Touch has a number of battery
power detect symbols:

When the Battery Pack starts to run low the Battery Low icon
will flash on the Main
Menu
screen.You will be allowed to continue to use the device. It is advised
that you plug in the 12V Power Supply to re-charge the batteries and
continue testing.

When the Battery Pack is approaching fully discharged
the Battery Discharged
icon will appear continuously on the Main Menu
screen.If you press any of the keys a warning message will appear and
you will not be allowed to proceed into any other screen. Plug in the
12V Power Supply to re-charge the batteries and continue testing.

6. Operating the Vitalograph ALPHA Touch

6.1
Entering Subject Information

After turning on the device, you are presented with the Main
Menu screen.

Select the Subject button, to bring you into the Select
Subject screen.

You can list the subjects saved on the device by selecting
either the Name or ID tab.

To
select a subject from the database, highlight the subject. This will
allow you the view the subject details. Select Enter to make
the
subject current.

To create a new subject, select the New tab.
Enter the subject details by hi-lighting the required field and typing
in the information using the touch panel keypad. Press the Enter button
to save the subject to the database and return to the Home Menu.

Note:
The current subject surname and forename will be displayed on the
bottom left hand corner of the screen. If the subject name is not
entered then the subject ID will be displayed. If the subject has test
session results associated with it then the subject name and ID will
appear in black. If there are no test session results then the subject
name and ID will appear in grey.

6.2
Performing a Test Session

Checks to Make before Performing a Test Session

Before starting a test session, there are a number of checks
which should be made:

Ensure that the accuracy of the Vitalograph ALPHA Touch
unit was checked recently. (Refer to the section on Checking Accuracy)

Ensure
a subject is selected (subject ID or name will appear on the status bar
at the bottom of the Main Menu) and the required demographic
information is entered for the subject.

Fit a disposable BVF mouthpiece. The use of a
disposable noseclip is also recommended.

Performing a VC Test

Perform the VC test as follows:

Select the ‘VC Test’ option from the Main Menu.

Wait for the ‘Exhale to Begin’ icon to appear.

This indicates that the
Vitalograph ALPHA Touch unit is ready to accept a blow.

Note: You can
view the results as either a Volume/time graph or a Volume bar graph by
selecting the relevant tab.

The
VC test can be performed using two methods. Read either of the
following instructions to the subject so that testing is performed
properly:

Method 1:

Sit upright, fit the nose clip and relax.

Keep the flowhead away from your mouth.

Inhale
as deeply as possible, hold your breath, then insert the mouthpiece
carefully into your mouth, clamping it gently between your teeth.

Seal your lips around the mouthpiece and keep your tongue
down.

Exhale
for as long as possible. It is vital that the operator encourages the
subject to keep exhaling to ensure all air is expelled.

Listen for two beeps. This indicates that Vitalograph ALPHA
Touch is ready for the next blow.

Method 2:

Note:
Method 2 can only be used when the Volume/Time (V/t) graph is selected
as the display option. This method cannot be used when the Volume bar
graph is selected as the display.

Sit upright, fit the noseclip and relax.

Insert the mouthpiece carefully into your mouth, clamping
it gently between your teeth.

Seal your lips around the mouthpiece and keep your tongue
down.

Breathe in and out normally. This is tidal breathing.

When you are happy that the subject has achieved steady tidal
breathing, continue with:

Exhale
for as long as possible. It is vital that the operator encourages the
subject to keep exhaling to ensure all air is expelled.

Inhale as deeply as possible (speed is not important) and
when fully inhaled.

Return to tidal breathing, i.e. breathe in and out normally
again.

The
VC values recorded for the blow are tabulated. The best VC value for
the current session and the Lower Limit of Normality (LLN) are also
displayed.

Repeat the blow three times or more to obtain good test
quality.

After performing the VC tests press the Cancel button to
exit the VC Test screen. This brings you back to the Main Menu.

Performing an FVC Test

Select the ‘FVC Test’ option from the Main Menu.

Wait for the ‘Exhale to Begin’ icon to
appear.

This indicates that the Vitalograph ALPHA Touch unit is ready to accept
a blow.

Note: You can view
the results as either a Volume/time (V/t) or a Flow/Volume
(F/V) graph by selecting the relevant tab.

The
FVC test can be performed using 2 methods as follows. Read either of
the following instructions to the subject so that testing is performed
properly:

Method 1:

Sit upright, fit the noseclip and relax.

Hold the unit, keeping it away from your mouth.

Inhale
as deeply as possible, hold your breath, then insert the mouthpiece
carefully into your mouth, clamping it gently between your teeth.

Seal your lips around the mouthpiece and keep your tongue
down.

Exhale
for as long as possible. Keep blowing for at least 6 seconds. (From the
very beginning of the blow the operator should encourage the subject to
keep going in a lively fashion. Keep eye contact with the subject)

If inspiratory indices are selected, then inhale as quickly
as possible.

Listen for two beeps. This indicates that Vitalograph ALPHA
Touch is ready for the next blow.

Method 2:

Sit upright, fit the noseclip and relax.

Insert the mouthpiece carefully into your mouth, clamping
it gently between your teeth.

Seal your lips around the mouthpiece and keep your tongue
down.

Breathe in and out normally. This is called tidal
breathing.

When you are happy that the subject has achieved steady tidal
breathing, continue with:

Inhale as deeply as possible

Exhale
for as long as possible. Keep blowing for at least 6 seconds. (From the
very beginning of the blow the operator should encourage the subject to
keep going in a lively fashion. Keep eye contact with the subject)

Inhale fully as quickly as possible

Return to tidal breathing, i.e. breathe in and out normally
again.

The
FVC, FEV1 and PEF values recorded for the blow are tabulated. The best
FVC, FEV1 and PEF for the current session are
displayed.

The test quality (QA) is shown at the top right of the test screen.

The
best 3 tests performed and the Test Grade are shown in the test screen.
Each test series is graded in relation to its repeatability between
acceptable manoeuvres. The quality Grades are A, B, C, D and F.

The repeatability (Within) of FVC and FEV1 are also shown. The
repeatability information is displayed if at least two tests are
performed. I Bars on the F/V graph are shown for FEF25, FEF50 and
FEF75. An I Bar for FVC is also shown on the Volume axis. The
upper mark on the I Bars indicates the predicted value for the subject.
The lower mark on the I Bar indicates the LLN value for the subject.
The I Bars are based on the predicted sets and will be shown if
sufficient subject demographics information is entered.

Repeat the blow three times or more to obtain good test
quality.

To view results select the results tab.

You
can view the results for each blow by selecting the up/down arrows on
the bottom of the screen. If any of the parameters are below the Lower
Limit of Normality (LLN), then they will be displayed in red, provided
the subject age, height and gender are entered.

To view the graph of the blow select the graph button on
the bottom of the screen.

You
can choose to manually accept or reject a blow using the drop down list
for User Acceptability on the top right of the screen.

You can view the trend graph by selecting the trend button
on the bottom left of the screen.

After performing the FVC tests press the Cancel button to exit the FVC
Test screen. This brings you back to the Main Menu.

Note:
The measurements obtained from a lung function test form part of the
various findings of a physician in the detection, diagnosis and control
of chest diseases. Spirometry may support or exclude diagnosis, but it
cannot make one.

6.3
Saving the Test Session

The test session is saved to the database by following the
on-screen messages.

Note:
If a compact flash card is inserted into the compact flash card
connector at the right side of the device, then all test blows and not
just the best three will be saved to the compact flash card. Results
are saved as per the format outlined in the European Respiratory
Journal, 2005; 26: Pages 319-338: ATS/ERS Task Force: Standardisation
of Lung Function Testing.

6.4
Performing a Post Test Session

A
Post test session can be performed on an FVC test session following the
administration of drugs. Post drug delivery performance is measured
versus pre delivery.

To perform a Post test:

Select ‘Post Mode’ from the Main Menu.

If
you want to perform a Post Test on the Pre-test Session just performed
select ‘Perform Post test on Current Subject’. This will return you to
the test screen. The text Post Mode will appear on the graph.

If you wish to perform a Post Test on a different subject
or Pre-test:

Select ‘Select Subject from List’.

A
message ‘Warning! Current test session will end. Do you want to save
the test session?’ will appear. Select Yes and the Select
Subject
screen will appear.

Select the subject you wish to
perform the Post test on, and the Select Test Session screen will
appear. Select the test session.

Note: The words Pre, VC or FVC or a combination of
these will appear after the session ID.

If the word Pre appears then a POST test session has
already been performed on this pre session.

If the word VC appears then a VC test has been done as
part of the pre-session.

If the word FVC appears then an FVC test has been
performed as part of the pre-session.

Press ‘Enter’ to bring you to the test screen. The text
Post Mode will appear on the graph.

Perform the Post FVC test as outlined in section Performing
a Test Session.

6.5
Permanent Storage of Pre-Test Sessions

The Post Mode
screen also gives you the option to save and recall test sessions to
and from a permanent storage location on the device. This permanent
storage does not get deleted when test sessions are sent to Spirotrac V
or printed. To access this option select ‘Permanent Storage’.

The Permanent Storage screen
gives you four options:

Save
Test to Permanent Storage: When this option is selected a message will
appear informing you of the memory location where the test session will
be saved. There are nine permanent memory locations on the Vitalograph
ALPHA Touch.

Load Test from Permanent Storage: When this option
is selected the list of permanent pre-test sessions will appear. Select
the required pre-test session from the list and select enter to bring
you into the Post Mode screen.

Delete Test from Permanent
Storage: When this option is selected the list of permanent pre-test
sessions will appear. Select the Test session you wish to delete and
press enter. This location will then be marked as ‘Empty’.

Delete
all Tests from Permanent Storage. When this option is selected a
warning message will appear:- ‘Do you want to delete all tests stored
in permanent storage?’. Press enter to delete all tests.

6.6
Printing and Viewing the Test Session

You can print the current test session for the subject by
selecting ‘Print’ from the
FVC Test screen.

The
Vitalograph ALPHA Touch has an internal printer. It can also be
connected through the USB port at the side of the unit to the
Vitalograph Reports Utility, so that the report can be printed via a
PC. The information printed on the session report can be configured to
suit individual requirements. Refer to section on Report Settings.

You can also select the Report option from the Main Menu. If you
already have a Current Subject selected the following options are
available:

Current
Test Session: You can select to print the current test session. To
print the current session, select the print icon at the top of the
session results screen.

Select Test Session: You can select a
test session for the current subject. To print the session, select the
print icon at the top of the session results screen.

All Test
Sessions: You can print all test sessions for the current subject but
only to a P.C. All test sessions can’t be printed using the internal
printer.

You can also print Test Session(s) from a different subject in
the database. This is done by selecting the ‘Select’ tab in the View and Report
screen. The following options are available:

Select
Test Session: You must first select a subject from the database, and
then select a test session for that subject. To print the selected
session, select the print icon at the top of the session results screen.

All
Test Sessions: This will print all test sessions performed on a subject
but only to a P.C. All test sessions can’t be printed using the
internal printer. When you select this option you must first select a
subject from the database.

All Test Sessions Between…: This
will print all sessions stored on the device between specified dates
but only to a P.C. This can’t be printed using the internal printer..
You must first select the dates.

The default test
parameters on the report will vary according to regional requirements.
Test parameters can be configured to suit individual requirements.
Refer to section on Parameters.

Note:
The internal (thermal) printout will fade over time when exposed to
light or heat. If a permanent record is required, photocopy
the
thermal printout or send the report to the Vitalograph Reports Utility.
Refer to the section on Configuration for information on selecting the
internal or Vitalograph Reports Option.

6.7 Clear
Results

If you wish to delete the current session you can do this as
follows:

Select the ‘Clear’ option from the Main Menu.

A
message will appear ‘Warning! Current Test Session Will End. Do you
want to save the test session?’ Select ‘Yes’ to save the
current
test session and return to the Main
Menu. Select ‘No’ to not save the current test session and
return to the Main Menu.
Select ‘C’ to cancel the operation and continue with the current test
session.

6.8
Checking Accuracy

All
spirometry standards (e.g. ATS/ERS/BTS/ANZRS) recommend on measuring
devices at least daily with a 3-L syringe to validate that the
instrument is measuring accurately. The Vitalograph ALPHA Touch should
never be outside accuracy limits unless damaged or in a fault
condition. In this event, see the fault-finding guide. In normal use,
calibration traceability certification is recommended as a part of the
routine annual service.

ATS recommendations require that the
difference between the volume measured by the spirometer and the volume
pumped into the spirometer from a syringe is within ±3%.

Follow these steps to check the accuracy of the unit.

Select Accuracy Check from the Main Menu using the
keypad.

Enter the Syringe volume and reference using the touch
panel keypad.

Depending
on how the device is configured you may be prompted to enter the
ambient temperature, humidity (0-99%), pressure (25-31 inHg or 850-1060
hPa-mbar) and altitude (1-8500m). Enter these values using the touch
panel keypad.

Pump air through the flowhead to bring it to
ambient temperature. If the flowhead has very recently been used for
testing or has come from a cold environment, its temperature should be
equilibrated with ambient by pumping air through it from the syringe
several times.

Press the ‘Enter’ key to bring you into the Accuracy Check
screen and follow the on-screen instructions.

Note: Press the ‘C’ key to exit
the Accuracy Check
screen and return to the Main
Menu. The accuracy check will not be logged to the
Vitalograph ALPHA Touch memory in this case.

If an Accuracy Check report is required, select the Report
option.

Note:
If the device is outside calibration, you will be given the option to
update the calibration. If you select this option you will be brought
through the accuracy check routine again.

When to Check Accuracy

In accordance with your own established procedures

After annual maintenance checks

After cleaning or disassembling spirometer for any reason

After adjusting calibration

If the flowhead or device has been dropped

6.9
Configuration Options

There
are a number of Configuration options available on the Vitalograph
ALPHA Touch device. To access these, select the ‘Configuration’ option
on the Main Menu. The options available are:

Test Preferences

This allows you to configure the test screen to your
requirements. The following options are available:

FVC
Display: You can select to show F/V (Flow-Volume) or V/T (Volume-Time)
Graph by default in the FVC test screen. Select the required option
from the drop down menu.

VC Display: You can select to show the Bar Graph or V/T
(Volume-Time) Graph by default in the VC test screen.

Test
Acceptance: This allows you to manually accept the tests performed, or
allow the device to determine test acceptability (automatic).

Graph Scale: This allows you to select the default graph
scale.

Posture: You can select to no posture selected, standing or
sitting.

Post
VC Test: If you have done a VC test in a pre test session and then go
to do a Post test on that session then the VC test screen will
automatically come up. By selecting ‘off’ in the drop down list you
will be brought directly into the FVC test screen.

Temperature:
By selecting ‘on’ in the drop down list, the device gives the user the
option to manually enter the ambient temperature as they go into the VC
or FVC test screens.

Database

This allows you to
manage the available memory on the device. The Management tab tells you
how much subject and test session memory has been used up. As with all
memory after a period of time and repeated use the memory becomes
fragmented. Because of this the total available memory is not being
used. In order to correct this, select the Defragment option. This
process may take several minutes to complete.

The Deletion
option allows the user to delete sessions. By selecting the relevant
box the session will be deleted from the device after being Printed.
(Either a print to an internal printer or sent to Vitalograph Reports).

You
are also given the option to ‘Select Test Session(s)’ for deletion, or
‘Delete Subject(s)’ from the device by pressing the relevant button
using the touch panel LCD.

Calibration

The
Vitalograph ALPHA Touch should never be outside accuracy limits unless
damaged or in a fault condition. In this event, see the fault-finding
guide. In normal use, calibration traceability certification is
recommended as a part of the routine annual service.

Select the Calibration Options menu. You are presented with
four options:

Calibration

Precision Syringe

Linearity

Accuracy Log

Calibration

Select Calibration from the Calibration screen.

Pump
air through the flowhead to bring it to ambient temperature.
If
the flowhead has very recently been used for testing or has come from a
cold environment, its temperature should be equilibrated with ambient
by pumping air through it from the syringe several times.

Press the ‘Enter’ key to bring you into the Calibration screen
and follow the on-screen instructions.

Note: Press the ‘C’ key to exit the Calibration
screen.

If a Calibration report is required select the Report
option.

Note: An Accuracy check must be done on the same day as the device is
calibrated.

Precision Syringe:

Select Precision Syringe from the Calibration screen.

Select the volume of the calibrated syringe you are using
from the drop down list.

Enter the syringe reference number using the touch panel
keypad.

Press ‘Enter’ to save the new volume entered and return to
the Calibration
screen. Press ‘C’ to cancel the changes made and return to the Calibration screen.

Linearity Check

Select Linearity from the Calibration screen.

Pump
air through the flowhead to bring it to ambient temperature.
If
the flowhead has very recently been used for testing or has come from a
cold environment, its temperature should be equilibrated with ambient
by pumping air.

Enter the environmental data if prompted to do so.

Press the ‘Enter’ key to bring you into the Linearity Check
screen.

Using
a 3L Calibrated syringe pump air into the flowhead at a slow rate of
<2L/s. Immediately withdraw the syringe at a slow rate. This
manoeuvre should show on the graph between the two red lines.
If
it is a correct manoeuvre the table on the screen will show ‘Test 1’,
and the FVC and FIVC values will be updated.

Note: Press the ‘C’
key to exit the Linearity
Check screen.

Repeat for the slow rate three times in total.

Repeat
the procedure outlined in step e for a medium rate >2L/s and
<6L/s. This manoeuvre should show on the graph between the red
and
green lines. If it is a correct manoeuvre the test number and the FVC
and FIVC values will be updated in the table.

Repeat for the medium rate three times in total.

Repeat
the procedure outlined in step e for a fast rate >6L/s. This
manoeuvre should show on the graph between the outside green lines. If
it is a correct manoeuvre the test number and the FVC and FIVC values
will be updated in the table.

Repeat for the fast rate three times in total.

When all the manoeuvres are complete press ‘Enter’ for the
result.

If a Linearity Check report is required select the Report
option.

Accuracy Log

Select Accuracy Log from the Calibration screen.
The accuracy log contains a record of all the accuracy checks done on
the device.

There are three options

To print the complete accuracy log press “Print All”.

To print a log of the last 30 accuracy tests done, press
“Print Last 30”.

To view the accuracy log, press “View”.

Press ‘C’ to return to the Calibration screen.

Settings

This allows you to adjust the settings of the device. The
following options are available in the Device Settings screen:

Date/Time

Units

Sound Options

Power Save Options

Incentive

Parameters

Date/Time

There are two tabs in this screen for the time and date.

In
order to change the time, scroll the hours and minutes to the required
settings by pressing the arrows on the touch panel LCD.

The time format can be changed from 24 hour to 12 hour by
switching On/Off the ’24 Hour Format’ option.

In
order to change the date, scroll the day, month and year to the
required settings by pressing the arrows on the touch panel LCD.

Units
The units used can be modified by selecting the alternative option
available on the drop down list:

Metric

US (Imperial)

Sound Options

This allows you to turn off and on the Key, Flow,
Error and Welcome sounds on the device. Simply select the on/off key
for the specific sound.

Adjust the volume by pressing the ‘-/+’ on the touch panel LCD.

Power Save Options

In
order to improve battery life you can configure the device to dull the
display after 3 minutes. This can be switched on or off.

Incentive

The Incentive Device is used as an aid in testing of children.

To change the incentive device to be used in testing,
select an
alternative for the Incentive Device drop down list. A preview of the
incentive will appear on the screen.

The % of predicted can be modified using the on-screen
keyboard. The value entered must be between 80-150.

The % of Best Test value can be modified using the
on-screen keyboard. The value entered must be between 80-150.

Parameters

This
gives a complete list of the test parameters that can be reported (and
printed) for a test session. To select/unselect a parameter
check/uncheck the relevant check boxes. Additional parameters are
available by selecting the additional index tabs.

The following list supplies definitions of the parameters:

Parameter

Definition

VC

Vital capacity (L)

IVC

Inspiratory vital capacity (L)

FIVC

Forced inspiratory vital
capacity (L)

FVC

Forced vital capacity (L)

FEV.5

Forced expiratory volume after
0.5 seconds (L)

FEV.75

Forced expiratory volume after
0.75 seconds (L)

FEV1

Forced expiratory volume after
1 second (L)

FEV3

Forced expiratory volume after
3 seconds (L)

FEV6

Forced expiratory volume after
6 seconds (L)

PEF L/s

Peak expiratory flow (L/sec)

PEF L/min

Peak expiratory flow (L/min)

FEF0.2-1.2

(F02-12)

Mean forced expiratory flow in
the volume interval between 0.2 and 1.2 L of the test (L/sec)

FEF 25-75

(F2575)

Maximal mid expiratory flow:
the mean FEF in the time interval between 25% and 75% of the FVC (L/sec)

FEF 75-85

(F7585)

Forced late expiratory flow:
the mean FEF in the time interval between 75% and 85% of the FVC (L/sec)

Lung age will be
displayed if the date of birth, height, population group and smoking
information have been entered.Lung
age will only be shown if the measured FEV1 value is less than the
lower limit of the predicted normal value for FEV1.

Subject Options

The following options are available in the Subject Options
screen:

Primary
View: The default view in which the subjects are listed can be set to
either name or ID. Select the required option from the drop down list.

The
device can be password protected, by setting the on/off button to the
on position. The password can be changed using the touch panel keypad

The
facility to enter Smoking History, Population Group and Weight can be
configured on or off when creating a new subject on the device. To
change the setting simply select the on/off button on the touch panel
keypad.

Smart Options

The Smart
Options allow you to set up the device to follow a set
sequence of operation on power up. In the Smart Options screen
you can set Smart on or off by selecting from the drop down list. When
set to on you are given four options:

After
Power Up: You can either configure the device to go to the Main Menu or
go to the Subject screen after power up. Select the required option
from the drop down list.

After Subject: You can configure the
device to go to VC Test, FVC Test or the Main Menu after selecting a
subject. Select the required option from the drop down list.

After
VC: You can configure the device to go to FVC or the Main Menu after
performing a VC test. Select the required option from the drop down
list.

After FVC: You can configure the device to go to POST
mode, Print the test or go to the Main Menu after performing an FVC
test. Select the required option from the drop down list.

Report Options

The Report Options screen allows you to set the Report Content
and the Report Method.

Report Content

The information printed on the session reports
can be configured to suit individual requirements. The following can be
configured in the report:

Table:
The device can be configured to show the results for the best test only
(Best 1) or the three best tests (Best 3). Select the required option
from the drop down list.

Normal Comparison: In the
session table of results either the % of Predicted value or the SDS
(Standard Deviation Score) will be printed. Select the required option
from the drop down list.

Test QA: The session report can be configured to show the
test QA. Select the required option to turn this on or off.

Interpretation:
The session report can be configured to show the device suggested
interpretation. Select the required option to turn this on or off.

Comments
Header: The session report can be configured to show a Comments Header.
Select the required option to turn this on or off.

Ambient
Conditions: The session report can be configured to show the Ambient
Conditions. The ambient conditions (Humidity, Pressure and Altitude)
are those entered when performing an accuracy check or calibration
update. Select the required option to turn this on or
off.

V/T
Size: The Volume/Time graph can be changed from standard to ATS/ERS
2005 (ATS) requirements. Select the required option from the drop down
list.

F/V Size: The Flow/Volume graph can be changed from
standard to ATS/ERS 2005 (ATS) requirements. Select the required option
from the drop down list.

V/T Graph: The session report
can be configured to show the V/T (Volume vs. Time) graph. Select the
required option to turn this on or off.

F/V Graph: The
session report can be configured to show the F/V (Flow vs. Volume)
graph. Select the required option to turn this on or off.

Trend
Graph: The session report can be configured to show the trend graph.
Select the required option to turn this on or off. The trend graph can
only be printed when the trend graph option and the configurable report
option are selected.

Report Method

The ALPHA Touch can print to the internal printer or
Vitalograph Reports. The following options are available:

Report: Select the option to either Send To PC or Internal
Printer from the drop down list.

Content:
The report can be set to the default report or the configurable report
option. Select the required option from the drop down list.

Colour:
The printout can be set to Colour or Black & White. Select on
for a
colour printout (print via a P.C), and off for black & white.

Note:
In order to send the report to the Vitalograph Reports Utility it is
necessary to have the Vitalograph Reports Utility installed on your PC
and the ALPHA Touch connected to your PC via a USB cable.

6.10
Fitting a New Paper Roll

The Vitalograph ALPHA Touch is supplied with a roll of paper
fitted into the printer.
(Note: The outside of the roll of paper will not give a strong print
impression due to loss of sensitivity on exposure to light).

To replace the paper follow the instructions listed below and shown in
figure 2.

Open the printer door to expose the head of the printer and
the paper cartridge.

Remove the paper cartridge that holds the empty paper roll
from the ALPHA Touch.

Remove the empty paper roll from the paper cartridge.

Put
the new roll of paper into the paper cartridge and unroll about 12cm (6
inches) of paper. (Note: To make fitting easier, create a point in the
middle of the paper by tearing or cutting the two corners of the
leading edge of the paper).

Clip the paper cartridge back
into place between the back of the Vitalograph ALPHA Touch unit and the
inside of the open door. The paper should be coming out from the bottom
of the roll and pointing towards the printer. This will allow you more
access to the printer feed mechanism.

In the home screen, lift the green lever on the printer.

Feed
the leading edge of the paper into the bottom slot of the printer until
the paper appears through the top of the printer. The paper can now be
pulled through. To aid in feeding the paper through the printer, press
the “Enter” key on the four button keypad. This will feed a short
length of paper through the printer.

Close the green lever.

Hold the paper over the paper tear bar and close the door.

Note: The Vitalograph
logo should be facing you on the right edge of the paper.

Warning: The paper tear bar
has sharp edges. Users should take care not to cut their fingers.

Figure 02

7. Cleaning Instructions

The parts of the Vitalograph
ALPHA Touch that make up the flowhead, which comes into contact with subjects
being tested, require low leveldisinfection.
The body of the device may be cleaned with an alcohol wipe.

A spirometer is not designed as a ‘sterile’ device.

A new BVF should be used with each subject to prevent cross contamination, the
BVF protects both the subject and the device.

One cleaning cycle should be
performed weekly.

It is recommended that the
complete flowhead and flowhead connection tube be replaced annually.

Table of Cleaning/Disinfection Methods

Part

Clean/Low Level Disinfection

Recommended Cleaning/Low Level Disinfection

Case Exterior

Clean

Wiping with a 70% isopropyl alcohol impregnated cloth.

Note: Ensure isopropyl alcohol does not come in contact with the screen.

Warning: Paper tear bar contains sharp edges. Users should take care not to cut/scrape their fingers.

Flowhead Tube

Clean

Flowhead Body

Clean

See section 7.2 for disassembling
and cleaning of flow head.

See section 7.3 for reassembling
and low level disinfection of the flowhead

Fleisch Element

Clean

Flowhead Cone

Clean & Low Level Disinfection

Flowhead End Cap

Clean & Low Level Disinfection

Flow Conditioning Meshes

Clean & Low Level Disinfection

Screen

Clean

Lightly wipe the surface with cotton pad or other soft material.
NOTE: DO NOT use chemicals such as acetone, toluene, ethanol or isopropyl alcohol. DO NOT wipe in a circular motion. Strokes should be either up/down or over/back.

7.2.
Disassembling and Cleaning of the
Fleisch Flowhead

Remove the cone and the end cap from the
flowhead.

Remove the flow conditioning meshes from
inside the cone and the end cap, and examine them for damage or
contamination. If they are damaged or blocked, discard and replace
with new parts.

To remove the flowhead body from the fleisch
element, place the fleisch element on a hard, flat surface. Push down on the flowhead body with thumbs
and forefingers until it reaches the flat surface. A final pulling and
twisting action will separate the parts.